FDA panel votes to expand use of Vertex cystic fibrosis drug



FDA panel votes to expand use of Vertex cystic fibrosis drug

(Reuters) – A U.S. Food and Drug Administration advisory panel on Tuesday voted 13-2 to recommend expanding approval of Vertex Pharmaceuticals Inc’s cystic fibrosis drug Kalydeco to include a wider range of patients with the rare lung disease, the company said.

The panel of experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United States.

The FDA usually follows recommendations of its advisory panels, but is not obligated to do so. The agency is expected to make its decision on the expanded approval by the end of the year, Vertex said.

The current approval of Kalydeco, known chemically as ivacaftor, covers about 2,600 people in North America, Europe and Australia with a different gene mutation. Vertex has forecast 2014 Kalydeco sales of 0 million to 0 million.

Sanford Bernstein analyst Geoffrey Porges said the expanded approval could add about 0 million to annual Kalydeco sales and 50 cents to 55 cents in earnings per share.

Kalydeco was the first drug approved that addresses the underlying cause of cystic fibrosis rather than just the symptoms of the life threatening disease. It helps improve breathing by clearing mucus from the airways.

Vertex is testing other drugs in combination with Kalydeco in hopes of being able to treat a larger portion of the CF population, which affects about 75,000 people in North America, Europe and Australia.

Vertex shares rose 1.6 percent to 9.95 in extended trading from their Nasdaq close at 8.16.

(Reporting by Bill Berkrot; Editing by Diane Craft)

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FDA panel votes to expand use of Vertex cystic fibrosis drug



FDA panel votes to expand use of Vertex cystic fibrosis drug

(Reuters) – A U.S. Food and Drug Administration advisory panel on Tuesday voted 13-2 to recommend expanding approval of Vertex Pharmaceuticals Inc’s cystic fibrosis drug Kalydeco to include a wider range of patients with the rare lung disease, the company said.

The panel of experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United States.

The FDA usually follows recommendations of its advisory panels, but is not obligated to do so. The agency is expected to make its decision on the expanded approval by the end of the year, Vertex said.

The current approval of Kalydeco, known chemically as ivacaftor, covers about 2,600 people in North America, Europe and Australia with a different gene mutation. Vertex has forecast 2014 Kalydeco sales of 0 million to 0 million.

Sanford Bernstein analyst Geoffrey Porges said the expanded approval could add about 0 million to annual Kalydeco sales and 50 cents to 55 cents in earnings per share.

Kalydeco was the first drug approved that addresses the underlying cause of cystic fibrosis rather than just the symptoms of the life threatening disease. It helps improve breathing by clearing mucus from the airways.

Vertex is testing other drugs in combination with Kalydeco in hopes of being able to treat a larger portion of the CF population, which affects about 75,000 people in North America, Europe and Australia.

Vertex shares rose 1.6 percent to 9.95 in extended trading from their Nasdaq close at 8.16.

(Reporting by Bill Berkrot; Editing by Diane Craft)

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FDA panel votes to expand use of Vertex cystic fibrosis drug



FDA panel votes to expand use of Vertex cystic fibrosis drug

(Reuters) – A U.S. Food and Drug Administration advisory panel on Tuesday voted 13-2 to recommend expanding approval of Vertex Pharmaceuticals Inc’s cystic fibrosis drug Kalydeco to include a wider range of patients with the rare lung disease, the company said.

The panel of experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United States.

The FDA usually follows recommendations of its advisory panels, but is not obligated to do so. The agency is expected to make its decision on the expanded approval by the end of the year, Vertex said.

The current approval of Kalydeco, known chemically as ivacaftor, covers about 2,600 people in North America, Europe and Australia with a different gene mutation. Vertex has forecast 2014 Kalydeco sales of 0 million to 0 million.

Sanford Bernstein analyst Geoffrey Porges said the expanded approval could add about 0 million to annual Kalydeco sales and 50 cents to 55 cents in earnings per share.

Kalydeco was the first drug approved that addresses the underlying cause of cystic fibrosis rather than just the symptoms of the life threatening disease. It helps improve breathing by clearing mucus from the airways.

Vertex is testing other drugs in combination with Kalydeco in hopes of being able to treat a larger portion of the CF population, which affects about 75,000 people in North America, Europe and Australia.

Vertex shares rose 1.6 percent to 9.95 in extended trading from their Nasdaq close at 8.16.

(Reporting by Bill Berkrot; Editing by Diane Craft)

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Abandoned Dumpster Dog Gets Adopted Into Loving Home




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Temecula, California Family Gives Oscar a Second Chance

A Chihuahua mix dog found in a dumpster still wearing his collar has found a new home where he will be loved. It is not known whether Oscar was stolen and then discarded, or otherwise ended up in the trash, but he is beginning and new and better life from now on.

The little dog that was discovered inside a Dumpster in the city of Jurupa Valley is now living comfortably in his new home.

A Temecula family adopted the 3-year-old Chihuahua mix on Wednesday, Oct. 15 from the Western Riverside County/City Animal Shelter. Oscar, as the shelter employees nicknamed the dog, headed home on Thursday, Oct. 16 because the pup still needed his neuter surgery. More than 100 calls came to the shelter from prospective adopters.

Victor Rocha and his family adopted Oscar and the former dumped dog will now be able to roam freely in the family’s 4,000-square-foot home with two other dog buddies, a 7-year-old Golden retriever and another rescued dog, a 2-year-old Labrador-Pit Bull mix. There’s also a Calico cat in the home that runs the place, said Mr. Rocha.

“We’re very happy that this poor dog is getting a second chance, thanks to Victor and his family,” Director Robert Miller said. “And it sounds like he’ll have plenty of room to live a great life.”

Mr. Rocha said he could not understand why anyone would abandon a dog in such a terrible manner. He came across an online article and saw the picture of Oscar in the Dumpster, looking up. The dog’s eyes called out to him, he said.

“I knew I had to save this dog and make him a part of our life,” he said. ”We’re going to make him a part of our family. “I think we’ll go walk on the beach and see how that goes.”

Roughly a month ago, a resident at a mobile home park in the 6000 block of Mission Boulevard in Jurupa Valley’s Rubidoux area discovered the dog inside a Dumpster. The resident told the manager, who then called Riverside County Animal Services.

Officer Tiffany Fuller retrieved the dog from the Dumpster on that Saturday morning, Sept. 13. The dog was slightly overheated, but otherwise his health was OK.

A collar around Chihuahua’s neck had the phrase, “I love My Dog.” Although shy at first, he warmed up to all the shelter employees, who nicknamed him Oscar, in a nod to the “Sesame Street” character. An owner of the 3-year-old Chihuahua mix never came forward and he did not have a microchip.

Riverside County Animal Services sought the public’s help in trying to determine who might have purposely harmed the dog. The story received significant media coverage, but officers didn’t receive information that led to an arrest.

The shelter shared a series of photos from the happy occasion of Oscar’s adoption, along with the video seen below.

Victor holds Oscar and talks about his decision to apply to adopt and the love he already feels for the pup:

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<via>





Dosckocil (Petmate) DDS28377 Sofa Dog Bed, 20 by 16-Inch- Random colors

Sheepskin sleep surface and decorative trim, with Suede bolster and gusset. Bottom is non-skid. Filled with high-loft, recycled polyester fiber fill that will make pets feel like they are on cloud nine. Machine washable for easy care. Sofa bed measures 20-inch length by 16-inch width.

Price: $11.98
Ebola nurse’s status upgraded to good from fair



Ebola nurse’s status upgraded to good from fair

Staff members of Texas Health Presbyterian Hospital gather outside the emergency room to show support for fellow nurse Nina Pham, in Dallas, Texas October 16, 2014.

Credit: Reuters/Jaime R. Carrero

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Ebola nurse’s status upgraded to good from fair



Ebola nurse’s status upgraded to good from fair

Staff members of Texas Health Presbyterian Hospital gather outside the emergency room to show support for fellow nurse Nina Pham, in Dallas, Texas October 16, 2014.

Credit: Reuters/Jaime R. Carrero

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Ebola nurse’s status upgraded to good from fair



Ebola nurse’s status upgraded to good from fair

Staff members of Texas Health Presbyterian Hospital gather outside the emergency room to show support for fellow nurse Nina Pham, in Dallas, Texas October 16, 2014.

Credit: Reuters/Jaime R. Carrero

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Milk substitutes might not give kids enough vitamin D



Milk substitutes might not give kids enough vitamin D

NEW YORK (Reuters Health) – Young children who drank nondairy replacement milks instead of cow’s milk were more like to have low levels of vitamin D in their blood, a new study found.

Parents often choose non-dairy beverages, such as almond, soy, or rice milk, for kids who have milk allergies or lactose intolerance. Some parents believe these beverages have health benefits even for kids who can drink regular milk.

“Parents ask their child’s doctor quite frequently whether alternate milk is good for their children,” Dr. Jonathon Maguire told Reuters Health in a phone call.

“And we as doctors have trouble answering that question – it depends on a lot of factors, and one of the things it depends on is whether they can maintain children’s vitamin D stores as well as cow’s milk,” said Maguire, a pediatrician at St. Michaels’ Hospital in Toronto, Ontario who led the study.

Vitamin D helps the body absorb calcium, so it’s essential for strong bones and teeth. It’s normally produced by the body after the skin is exposed to sunlight. Manufacturers also add it to certain foods, such as milk and dairy products.

In the U.S. and Canada, cow’s milk must be fortified with vitamin D, but there is no such requirement for non-dairy alternatives, Maguire said.

“Our findings suggest that children are about half as likely to maintain adequate vitamin D levels when drinking non-cow’s milk and it behooves us as parents to be aware that both in Canada and United States, non-cow’s milk is not legislated to contain vitamin D,” Maguire said.

For a study reported in the Canadian Medical Association Journal, Maguire and colleagues collected information on amounts and types of milk consumed by 2,831 Toronto preschoolers who also had tests for vitamin D levels.

Eighty-seven percent of the children drank predominantly cow’s milk, and 13 percent drank non-cow’s milk.

The researchers found low vitamin D levels in 5 percent of children who drank only cow’s milk, compared to 11 percent of children who drank only the milk substitutes.

“I think on our end as physicians, children who can’t drink cow’s milk or parents who choose non-cow’s
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Americans back travel ban from Ebola outbreak countries: Reuters/Ipsos poll



Americans back travel ban from Ebola outbreak countries: Reuters/Ipsos poll

Protestor Jeff Hulbert of Annapolis, Maryland holds a sign as he demonstrates in favor of a travel ban to stop the spread of the Ebola virus, in front of the White House in Washington October 16, 2014.

Credit: Reuters/Jim Bourg

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Americans back travel ban from Ebola outbreak countries: Reuters/Ipsos poll



Americans back travel ban from Ebola outbreak countries: Reuters/Ipsos poll

Protestor Jeff Hulbert of Annapolis, Maryland holds a sign as he demonstrates in favor of a travel ban to stop the spread of the Ebola virus, in front of the White House in Washington October 16, 2014.

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Americans back travel ban from Ebola outbreak countries: Reuters/Ipsos poll



Americans back travel ban from Ebola outbreak countries: Reuters/Ipsos poll

Protestor Jeff Hulbert of Annapolis, Maryland holds a sign as he demonstrates in favor of a travel ban to stop the spread of the Ebola virus, in front of the White House in Washington October 16, 2014.

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Recalled, drug-tainted supplements still available for purchase



Recalled, drug-tainted supplements still available for purchase

(Reuters Health) – Long after the Food and Drug Administration (FDA) issued recalls for dietary supplements tainted with banned drugs, more than half of the tainted supplements were still available for purchase, a new study found.

“There’s no question that these supplements that contain pharmaceuticals are not allowed to be sold, there are clear cut laws,” lead author Dr. Pieter A. Cohen told Reuters Health by phone.

The FDA does have some loose regulatory power over supplements, which are categorized like a food, Cohen said.

If a food manufacturer’s product were tainted with salmonella, the tainted food would be recalled, the factory cleaned, and then manufacturing would continue, Cohen said. In the case of supplements, the FDA issues recalls for products tainted with dangerous pharmaceuticals, but without proper enforcement the tainted products remain on the market and some companies continue to produce more, he said.

The FDA has identified more than 400 supplement brands tainted with pharmaceuticals, and issued a recall for 70 percent of the products.

Cohen and his coauthors studied 27 of the 274 supplements the FDA recalled between 2009 and 2012, two-thirds of which were American-made. They bought the supplements from manufacturer websites at least eight months and up to four years after their FDA recall, then tested their chemical makeup.

The researchers found that 18 of the 27 supplements they purchased still contained a pharmaceutical adulterant, according to results in JAMA.

The supplements were marketed for sports enhancement, weight loss and sexual enhancement, among other things.

Among the banned substances in the products were sibutramine, a weight loss drug linked to heart attack and stroke, and phenolphthalein, a laxative being removed from many markets due to a potential link to cancer.

“Dietary supplement manufacturers and distributors are legally responsible for marketing a safe product that is not adulterated, and that complies with FDA’s good manufacturing practice regulations for dietary supplements,” the FDA told Reuters Health in a statement.

But, the FDA warned, “The supply chain for these products is extremely fragmented; one product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States. The
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Recalled, drug-tainted supplements still available for purchase



Recalled, drug-tainted supplements still available for purchase

(Reuters Health) – Long after the Food and Drug Administration (FDA) issued recalls for dietary supplements tainted with banned drugs, more than half of the tainted supplements were still available for purchase, a new study found.

“There’s no question that these supplements that contain pharmaceuticals are not allowed to be sold, there are clear cut laws,” lead author Dr. Pieter A. Cohen told Reuters Health by phone.

The FDA does have some loose regulatory power over supplements, which are categorized like a food, Cohen said.

If a food manufacturer’s product were tainted with salmonella, the tainted food would be recalled, the factory cleaned, and then manufacturing would continue, Cohen said. In the case of supplements, the FDA issues recalls for products tainted with dangerous pharmaceuticals, but without proper enforcement the tainted products remain on the market and some companies continue to produce more, he said.

The FDA has identified more than 400 supplement brands tainted with pharmaceuticals, and issued a recall for 70 percent of the products.

Cohen and his coauthors studied 27 of the 274 supplements the FDA recalled between 2009 and 2012, two-thirds of which were American-made. They bought the supplements from manufacturer websites at least eight months and up to four years after their FDA recall, then tested their chemical makeup.

The researchers found that 18 of the 27 supplements they purchased still contained a pharmaceutical adulterant, according to results in JAMA.

The supplements were marketed for sports enhancement, weight loss and sexual enhancement, among other things.

Among the banned substances in the products were sibutramine, a weight loss drug linked to heart attack and stroke, and phenolphthalein, a laxative being removed from many markets due to a potential link to cancer.

“Dietary supplement manufacturers and distributors are legally responsible for marketing a safe product that is not adulterated, and that complies with FDA’s good manufacturing practice regulations for dietary supplements,” the FDA told Reuters Health in a statement.

But, the FDA warned, “The supply chain for these products is extremely fragmented; one product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States. The
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Recalled, drug-tainted supplements still available for purchase



Recalled, drug-tainted supplements still available for purchase

(Reuters Health) – Long after the Food and Drug Administration (FDA) issued recalls for dietary supplements tainted with banned drugs, more than half of the tainted supplements were still available for purchase, a new study found.

“There’s no question that these supplements that contain pharmaceuticals are not allowed to be sold, there are clear cut laws,” lead author Dr. Pieter A. Cohen told Reuters Health by phone.

The FDA does have some loose regulatory power over supplements, which are categorized like a food, Cohen said.

If a food manufacturer’s product were tainted with salmonella, the tainted food would be recalled, the factory cleaned, and then manufacturing would continue, Cohen said. In the case of supplements, the FDA issues recalls for products tainted with dangerous pharmaceuticals, but without proper enforcement the tainted products remain on the market and some companies continue to produce more, he said.

The FDA has identified more than 400 supplement brands tainted with pharmaceuticals, and issued a recall for 70 percent of the products.

Cohen and his coauthors studied 27 of the 274 supplements the FDA recalled between 2009 and 2012, two-thirds of which were American-made. They bought the supplements from manufacturer websites at least eight months and up to four years after their FDA recall, then tested their chemical makeup.

The researchers found that 18 of the 27 supplements they purchased still contained a pharmaceutical adulterant, according to results in JAMA.

The supplements were marketed for sports enhancement, weight loss and sexual enhancement, among other things.

Among the banned substances in the products were sibutramine, a weight loss drug linked to heart attack and stroke, and phenolphthalein, a laxative being removed from many markets due to a potential link to cancer.

“Dietary supplement manufacturers and distributors are legally responsible for marketing a safe product that is not adulterated, and that complies with FDA’s good manufacturing practice regulations for dietary supplements,” the FDA told Reuters Health in a statement.

But, the FDA warned, “The supply chain for these products is extremely fragmented; one product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States. The
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Giving pricey hepatitis drug to prisoners may be financially wise



Giving pricey hepatitis drug to prisoners may be financially wise

(Reuters Health) – When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty price tag, according to a new study.

Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

“Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.,” Jeremy Goldhaber-Fiebert told Reuters Health.

“It allows us to ask a variety of ‘what-if’ questions and probe how sensitive our findings are to various factors,” said Goldhaber-Fiebert, the study’s senior author from Stanford University in California.

Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs – but before 1992 hepatitis C was also transmitted by blood transfusions.)

When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

The U.S. Food and Drug Administration (FDA) approved Merck’s Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective – and more expensive (see Reuters story of May 13, 2011 here: reut.rs/1yg9GGm).

Then, the FDA approved Gilead’s Sovaldi,
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Giving pricey hepatitis drug to prisoners may be financially wise



Giving pricey hepatitis drug to prisoners may be financially wise

(Reuters Health) – When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty price tag, according to a new study.

Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

“Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.,” Jeremy Goldhaber-Fiebert told Reuters Health.

“It allows us to ask a variety of ‘what-if’ questions and probe how sensitive our findings are to various factors,” said Goldhaber-Fiebert, the study’s senior author from Stanford University in California.

Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs – but before 1992 hepatitis C was also transmitted by blood transfusions.)

When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

The U.S. Food and Drug Administration (FDA) approved Merck’s Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective – and more expensive (see Reuters story of May 13, 2011 here: reut.rs/1yg9GGm).

Then, the FDA approved Gilead’s Sovaldi,
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Giving pricey hepatitis drug to prisoners may be financially wise



Giving pricey hepatitis drug to prisoners may be financially wise

(Reuters Health) – When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty price tag, according to a new study.

Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

“Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.,” Jeremy Goldhaber-Fiebert told Reuters Health.

“It allows us to ask a variety of ‘what-if’ questions and probe how sensitive our findings are to various factors,” said Goldhaber-Fiebert, the study’s senior author from Stanford University in California.

Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs – but before 1992 hepatitis C was also transmitted by blood transfusions.)

When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

The U.S. Food and Drug Administration (FDA) approved Merck’s Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective – and more expensive (see Reuters story of May 13, 2011 here: reut.rs/1yg9GGm).

Then, the FDA approved Gilead’s Sovaldi,
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MSF aims to start drug trials in Ebola clinics next month



MSF aims to start drug trials in Ebola clinics next month

A volunteer for Medecins Sans Frontieres (MSF) receives training on how to handle personal protective equipment during courses in Brussels October 15, 2014, which is aimed to help deal with the Ebola disease in West Africa.

Credit: Reuters/Francois Lenoir

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MSF aims to start drug trials in Ebola clinics next month



MSF aims to start drug trials in Ebola clinics next month

A volunteer for Medecins Sans Frontieres (MSF) receives training on how to handle personal protective equipment during courses in Brussels October 15, 2014, which is aimed to help deal with the Ebola disease in West Africa.

Credit: Reuters/Francois Lenoir

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MSF aims to start drug trials in Ebola clinics next month



MSF aims to start drug trials in Ebola clinics next month

A volunteer for Medecins Sans Frontieres (MSF) receives training on how to handle personal protective equipment during courses in Brussels October 15, 2014, which is aimed to help deal with the Ebola disease in West Africa.

Credit: Reuters/Francois Lenoir

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REFILE-MSF aims to start drug trials in Ebola clinics next month - Reuters




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Dopps Chiropractic
4746 S. Broadway
Wichita, Ks 67216
(316) 522-1122
http://ift.tt/14R1IJ3

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